Collapsible-expandable heart valves

Abstract

A prosthetic heart valve can include a valve frame having a wireform portion and a stent portion. The wireform and stent portions can be undetachably coupled together via a plurality of upright struts so as to form a one-piece prosthetic heart valve frame. Alternatively, a self-expanding wireform portion and a balloon-expandable stent portion can be coupled together via one or more leaflets and a subassembly having a flexible leaflet support stent and a sealing ring. The wireform portion can include cusps and commissures configured to support a plurality of leaflets. The prosthetic valve can be radially collapsible for minimally invasive and/or transcatheter delivery techniques. Disclosed embodiments can also provide flexion of the wireform portion (e.g., of the commissures) in response to physiologic pulsatile loading when the valve is implanted in a patient's native valve annulus. Methods of making and using prosthetic heart valves are also disclosed.

What is claimed is: 
     
       1. A prosthetic heart valve for implant at a patient's aortic annulus having a fibrous shelf between an upstream left ventricle and a downstream aorta, comprising: a collapsible-expandable one-piece frame having a stent portion and a leaflet support portion, the frame being formed of superelastic material and extending along an axis from an inflow end to an outflow end, the leaflet support portion having around a frame periphery a continuous wire structure with alternating arcuate cusps on an inflow end and upstanding commissure supports projecting toward an outflow end together defining an undulating structure, the leaflet support portion having a cloth covering extending at least along the alternating arcuate cusps; and three flexible bioprosthetic leaflets each having an arcuate cusp portion between two commissure portions, each arcuate cusp portion being co-extensive and secured to the cloth covering around one of the leaflet support portion alternating arcuate cusps, and each commissure portion being secured to the commissure portions of each adjacent leaflet and each secured pair of commissure portions being secured to one of the upstanding commissure supports of the leaflet support portion, wherein a first one of the stent portion and leaflet support portion is configured to collapse to a smaller diameter than a second one of the stent portion and leaflet support portion, and wherein the stent portion is configured to engage an inner periphery of a body lumen at the aortic annulus implantation site. 
     
     
       2. The heart valve of  claim 1 , wherein the stent portion is configured to engage the aortic annulus upstream of the fibrous shelf. 
     
     
       3. The heart valve of  claim 1 , wherein the stent portion is configured to engage the aorta wall downstream of the fibrous shelf. 
     
     
       4. The heart valve of  claim 1 , wherein the stent portion comprises a plurality of axially-oriented struts spaced around the frame periphery and connected by a plurality of rows of collapsible-expandable bent struts that allow the stent portion to radially collapse to a compressed configuration for delivery and facilitate expansion of the stent portion so as to engage the inner periphery of the body lumen. 
     
     
       5. The heart valve of  claim 4 , wherein some of the axially-oriented struts couple the stent portion to the leaflet support portion. 
     
     
       6. The heart valve of  claim 5 , wherein the leaflet support portion is positioned at the outflow end of the frame in series with the stent portion at the inflow end, wherein the plurality of axially-oriented struts that couple the stent portion to the leaflet support portion are aligned with and couple directly to terminal ends of the upstanding commissure supports of the leaflet support portion. 
     
     
       7. The heart valve of  claim 6 , wherein an outflow end of the stent portion extends around the frame periphery with an undulating shape that extends along and adjacent to the alternating arcuate cusps of the leaflet support portion. 
     
     
       8. The heart valve of  claim 6 , wherein each adjacent pair of leaflet commissure portions passes radially outward between struts of one of the upstanding commissure supports and is secured to the corresponding axially-oriented strut at that upstanding commissure support. 
     
     
       9. The heart valve of  claim 6 , wherein each axially-oriented strut extends substantially from the inflow end to the outflow end of the frame. 
     
     
       10. The heart valve of  claim 1 , further including a compressible sealing ring positioned around the inflow end of the leaflet support portion with an undulating shape that tracks along the alternating arcuate cusps of the leaflet support portion. 
     
     
       11. A prosthetic heart valve for implant at a patient's aortic annulus having a fibrous shelf between an upstream left ventricle and a downstream aorta, comprising: a collapsible-expandable one-piece frame having a stent portion and a leaflet support portion, the frame being formed of superelastic material and extending along an axis from an inflow end to an outflow end, wherein a first one of the stent portion and leaflet support portion is configured to collapse to a smaller diameter than a second one of the stent portion and leaflet support portion such that the stent portion and leaflet support portion axially overlap when collapsed, and the leaflet support portion having around a frame periphery a continuous wire structure with alternating arcuate cusps on an inflow end and upstanding commissure supports projecting toward an outflow end together defining an undulating structure, the leaflet support portion having a cloth covering extending at least along the alternating arcuate cusps; and three flexible bioprosthetic leaflets each having an arcuate cusp portion between two commissure portions, each arcuate cusp portion being co-extensive and secured to the cloth covering around one of the leaflet support portion alternating arcuate cusps, and wherein the stent portion is configured to engage an inner periphery of a body lumen at the aortic annulus implantation site. 
     
     
       12. The heart valve of  claim 11 , wherein the stent portion is configured to engage the aortic annulus upstream of the fibrous shelf. 
     
     
       13. The heart valve of  claim 11 , wherein the stent portion is configured to engage the aorta wall downstream of the fibrous shelf. 
     
     
       14. The heart valve of  claim 11 , wherein the leaflet support portion is positioned at the outflow end of the frame in series with the stent portion at the inflow end of the frame. 
     
     
       15. The heart valve of  claim 14 , wherein the leaflet support portion is configured to collapse to a smaller diameter than the stent portion such that the alternating arcuate cusps of the leaflet support portion may be positioned within an outflow end of the stent portion and axially overlap when the frame is collapsed. 
     
     
       16. The heart valve of  claim 14 , wherein the stent portion comprises a plurality of axially-oriented struts spaced around the frame periphery and connected by a plurality of rows of collapsible-expandable bent struts that allow the stent portion to radially collapse to a compressed configuration for delivery and facilitate expansion of the stent portion so as to engage the inner periphery of the body lumen, and wherein an outflow end of the stent portion is defined by the plurality of axially-oriented struts. 
     
     
       17. The heart valve of  claim 14 , wherein the stent portion comprises a plurality of axially-oriented struts spaced around the frame periphery and connected by a plurality of rows of collapsible-expandable bent struts that allow the stent portion to radially collapse to a compressed configuration for delivery and facilitate expansion of the stent portion so as to engage the inner periphery of the body lumen, and wherein an outflow end of the stent portion is defined by a circumferential strut that is relatively straight when the frame is in an expanded configuration and bent or folded when the frame is in a compressed configuration. 
     
     
       18. The heart valve of  claim 11 , wherein the leaflet support portion alternating arcuate cusps each has a central thinned portion configured to deform more readily than adjacent, thicker, areas of the alternating arcuate cusps configured to facilitate collapse of the leaflet support portion. 
     
     
       19. The heart valve of  claim 11 , further including an external restraint comprising at least one suture threaded through the upstanding commissure supports and tensioned to hold the upstanding commissure supports in a compressed configuration. 
     
     
       20. The heart valve of  claim 11 , further including a compressible sealing ring positioned around the inflow end of the leaflet support portion with an undulating shape that tracks along the alternating arcuate cusps of the leaflet support portion.